Company Interview / BlinkLab nearing FDA liftoff

Key points:

Blinklab (ASX: BB1) completes US pilot study for AI-based autism & ADHD assessment tool Next phase is a pivotal 510(k) FDA study launching in early 2026 Tool aims to reduce diagnostic wait times by offering neuroscience-based digital assessments Parallel ADHD study results to be announced early 2026

Blinklab is advancing the early detection of autism and ADHD with its AI-powered, smartphone-based neural network tool, according to Henk-Jan Boele. Having recently completed a US pilot study involving 485 children aged 2 to 11, Boele states the clinical evaluation for autism was compared against Blinklab’s digital assessments, aiming to demonstrate broader clinical value. The device, grounded in fundamental neuroscience, is positioned to alleviate the lengthy waitlists for autism and ADHD assessments, which currently take between 3 to 8 hours per child.

Boele outlines that the next step is a pivotal 510(k) FDA study, set to commence in early 2026. Pending FDA clearance, the company plans to launch the tool in the US market. The technology utilises defined machine learning algorithms, focusing on neurological assessments of sensory motor processing, rather than relying on “black box” AI. Boele emphasises that this clinical approach aims to democratise access to diagnosis and improve outcomes for children and families.

Looking ahead, Boele highlights plans to announce more hospitals joining the upcoming pivotal study and parallel progress on an ongoing ADHD trial. Updates regarding initial results from the ADHD study are expected in early 2026, marking significant milestones for both the company and its shareholders.